CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials
Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.
Authors
- R. Tunn (ORCID: https://orcid.org/0000-0003-1187-1808)
- Rakesh Aggarwal (ORCID: https://orcid.org/0000-0001-9689-494X)
- Martin Offringa (ORCID: https://orcid.org/0000-0002-4402-5299)
- Lehana Thabane (ORCID: https://orcid.org/0000-0003-0355-9734)
- Brennan C Kahan (ORCID: https://orcid.org/0000-0001-9957-0844)
- Dawn P. Richards (ORCID: https://orcid.org/0000-0003-1151-0826)
- Michael Berkwits (ORCID: https://orcid.org/0000-0001-5962-2857)
- R. S. Taylor (ORCID: https://orcid.org/0000-0002-3043-6011)
- Nita Bhandari (ORCID: https://orcid.org/0000-0003-0349-087X)
- Sophie H. Staniszewska (ORCID: https://orcid.org/0000-0002-7723-9074)
- Sally Hopewell (ORCID: https://orcid.org/0000-0002-6881-6984)
- Philippe Ravaud (ORCID: https://orcid.org/0000-0001-8264-9206)
- Jesse A. Berlin (ORCID: https://orcid.org/0000-0002-9810-745X)
- An‐Wen Chan (ORCID: https://orcid.org/0000-0002-4498-3382)
- Elizabeth Loder (ORCID: https://orcid.org/0000-0003-1501-2947)
- Runcie C.W. Chidebe (ORCID: https://orcid.org/0000-0002-6025-776X)
- Kenneth F. Schulz (ORCID: https://orcid.org/0000-0003-2596-7616)
- Diana Elbourne (ORCID: https://orcid.org/0000-0003-3044-4545)
- Ian R. White (ORCID: https://orcid.org/0000-0002-6718-7661)
- Steven N. Goodman (ORCID: https://orcid.org/0000-0002-3872-5723)
- Professor Gary S. Collins (ORCID: https://orcid.org/0000-0002-2772-2316)
- Andrew A. Farmer (ORCID: https://orcid.org/0000-0002-6170-4402)
- Isabelle Boutron (ORCID: https://orcid.org/0000-0002-5263-6241)
- Dean Fergusson (ORCID: https://orcid.org/0000-0002-3389-2485)
- Steff Lewis (ORCID: https://orcid.org/0000-0003-1210-2314)
- David Moher (ORCID: https://orcid.org/0000-0003-2434-4206)
- Sarah E Lamb (ORCID: https://orcid.org/0000-0003-4349-7195)
- John P. A. Ioannidis (ORCID: https://orcid.org/0000-0003-3118-6859)
- Sunita Vohra (ORCID: https://orcid.org/0000-0002-6210-7933)
- Nancy J. Butcher (ORCID: https://orcid.org/0000-0002-5152-0108)
- David L. Schriger (ORCID: https://orcid.org/0000-0003-0242-1127)
- Nandi Siegfried (ORCID: https://orcid.org/0000-0002-4081-1698)
- Marion Campbell (ORCID: https://orcid.org/0000-0001-5386-4097)
- Frank W. Rockhold (ORCID: https://orcid.org/0000-0003-3732-4765)
- Tammy Hoffmann (ORCID: https://orcid.org/0000-0001-5210-8548)
- Rachel L Knowles (ORCID: https://orcid.org/0000-0002-5490-7682)
- David Torgerson (ORCID: https://orcid.org/0000-0002-1667-4275)
- Robert M. Golub (ORCID: https://orcid.org/0009-0000-3270-0632)
- Asbjørn Hróbjartsson (ORCID: https://orcid.org/0000-0002-2451-5012)
Institutions
- Rutgers, The State University of New Jersey (US)
- South African Medical Research Council (ZA)
- Northwestern University (US)
- University of North Carolina at Chapel Hill (US)
- Bond University (AU)
- Centers for Disease Control and Prevention (US)
- Harvard University (US)
- University of Alberta (CA)
- Inserm (FR)
- University of California, Los Angeles (US)
- University of Southern Denmark (DK)
- University of Toronto (CA)
- University of Aberdeen (GB)
- Université Paris Cité (FR)
- University of Exeter (GB)
- Great Ormond Street Hospital (GB)
- Ottawa Hospital (CA)
- Hospital for Sick Children (CA)
- Odense University Hospital (DK)
- Women's College Hospital (CA)
- University of Warwick (GB)
- Sorbonne Université (FR)
- University of Oxford (GB)
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR)
- Clinical Research Institute (US)
- London School of Hygiene & Tropical Medicine (GB)
- Université Sorbonne Paris Nord (FR)
- MRC Clinical Trials Unit at UCL (GB)
- Sorbonne Paris Cité (FR)
- Society for Applied Studies (IN)
- Assistance Publique – Hôpitaux de Paris (FR)
- Centers for Disease Control and Prevention (UG)
- Robarts Clinical Trials (CA)
- MRC/CSO Social and Public Health Sciences Unit (GB)
- Open Invention Network (United States) (US)
- Duke Medical Center (US)
- Protein Metrics (United States) (US)
- NIHR Exeter Clinical Research Facility (GB)
- Hôtel-Dieu de Paris (FR)
- Cochrane (DK)
- Centers for Disease Control and Prevention (KE)
- Oxford BioMedica (United Kingdom) (GB)
- Impact (CA)
- Centre de Recherche Épidémiologie et Statistique (FR)
- Ottawa Hospital Research Institute (CA)
- University College London (GB)
- University of York (GB)
- St. Joseph’s Healthcare Hamilton (CA)
- Jawaharlal Institute of Post Graduate Medical Education and Research (IN)
- University of Glasgow (GB)
- Miami University (US)
- Stanford University (US)
- McMaster University (CA)
- University of Edinburgh (GB)
Publication Details
- Journal
- BMJ
- Published
- 2025-04-14
- DOI
- https://doi.org/10.1136/bmj-2024-081124
- Citations
- 100
- Primary Topic
- Delphi Technique in Research
- Type
- article
- Field-Weighted Citation Impact
- 420.15